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Identification and Barcoding of Medicinal Products for Human Use. 1. Objective and Scope .

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1 objective and scope
1. Objective and Scope

JFDA adopted the following instructions for the purpose of improving Jordan healthcare supply chain efficiency, inventory management , combat counterfeiting as well as cost savings by means of capture technology, electronic storage and transmission of data.

  • All stakeholders need to work to commonly agreed standards if the benefits are to be realized fully. Using GS1 Standards and bar code requirements at various levels of product packaging.

This will also help Jordan Healthcare sector to develop their investment strategy to be complied with global healthcare new developments and to build the infrastructure that is adequate with new modern technologies this will lead to improve Patient safety and reduce costs.

MOH & JFDA are working to build their Databases in order to enable drug verification and control stock managementas well as to control and manage prices of pharmaceutical products.

benefits
Benefits

AIDC systems use globally unique Identifiers encoded within specific bar code symbols to identify all the items involved in healthcare: the improvements seen are the result of fewer medication errors and enhanced record keeping. Using unique identifiers such as GS1 "Keys" to manage supplies and purchase electronically can cut costs dramatically as well as improve efficiency. Unique identifiers encoded in machine readable bar code symbols provide the means to differentiate all the items involved in the healthcare supply chain. This ability, when linked with providing an item’s batch number or serial number together with its expiry date, enables the traceability of all healthcare products from production to delivery to the patient (point-of-care). 

2 definitions
2. Definitions

Healthcare Primary Packaging

The first level of packaging for the product marked with an AIDC data carrier either on the packaging or on a label affixed to the packaging. For non-sterile packaging, the first level of packaging can be the packaging in direct contact with the product. For sterile packaging, the first level of packaging can be any combination of the sterile packaging system, May consist of a single item or group of items for a single therapy such as a Kit. For packaging configurations that include a retail consumer trade item, primary packaging is a packaging level below the retail consumer trade item.

Healthcare Secondary Packaging

Healthcare Secondary Packagingis defined as a level of packaging that may contain one or more primary packages or a group of primary packages containing a single item. A secondary package can for example be a box containing one or more tubes, bottles of pills, blister packs or similar products.

Case / Shipper

These are packaging configurations that may be used as either trade items or logistic units. Case / shippers may contain one or more items in their Primary Packaging and/or Secondary Packaging. Pallets may contain one or more case / Shippers.

3 identification of products mandatory
3. Identification of Products (Mandatory)

a) GTINs (Global Trade Item Numbers): The GTIN is the GS1 Identification "Key" used to uniquely identify each product type/variant. It is a number composed of at most 14 digits used to uniquely identify products on a global scale. GTIN is allocated by Jordan Numbering Association (GS1 Jordan).

Generation of GTINs:

Please Note: - The company prefix number in this manual is only an example. The supplying company has to use the company prefix number issued by GS1 Jordan or any other GS1 member organizations in other countries.

GTIN -13:

Data structure and format of GTIN-13

1) The company prefix number allocated by GS1 Jordan to your company

2) Item reference number (Variable length dependent on length of company prefix number allocated)

3) Check Digit

Example:

In this example, we have

  • Used company prefix number “62512345”
  • Assigned item reference number “0001”
  • Calculated Check Digit “ 7”
identification of products mandatory
Identification of Products (Mandatory)

GTIN -12:

Data structure and format (GTIN – 12):

1) Company prefix number allocated by GS1 Jordan on registration

2) Item reference number (Variable length dependent on length of company prefix number allocated)

3) Check Digit

GTIN -8:

The structure of GTIN – 8:

All GTIN 8 product codes are always allocated by GS1 Jordan.

Example:

identification of products mandatory1
Identification of Products (Mandatory)

GTIN-14:

Data structure and format (GTIN – 14):

  • In this example we have generated GTIN-14 from GTIN-13. GTIN-14 can also be generated from GTIN-13, GTIN-12 & GTIN-8. Please refer to GS1 General Specifications on the use of indicator digit in healthcare.

1) The company prefix number allocated by GS1 Jordan.

2) Item reference number (Variable length, dependent on length of company prefix number allocated)

3) Check Digit

Example:Using the company prefix “62512345”

In this example

  • Use “0” as Indicator Digit* to generate GTIN-14 from a GTIN-13
  • GS1 company prefix number is “62512345”
  • Item reference number “ 0001”
  • Check Digit. This uses the previous 13 digits as per pre-defined algorithm, to calculate the fourteenth digit i.e. the check digit. In this example “7”.
slide8

Attributes GS1 Application Identifiers are a finite set of defined identifiers used to connect physical things and logical things to information or business messages related to them. The definitions for them reside in a standard called the GS1 General Specifications.

  • b) Application Identifiers (AIs) - for Additional Information
  • Following are examples of Application Identifiers (AIs) that are used in the Healthcare,
  • there are over 100 GS1 AIs in total.

- Application Identifier – AI (10) – Batch/Lot number:

Example: (10) ABC1234

- Application Identifier – AI (17) - Expiration date:

Example: (17) 010113 : 01January 2013

Application Identifier – AI (21) - Serial number:

Example: (21) 11005566SN

- Application Identifier – AI (7004) - Active Potency

- Application Identifier – AI (8008) - Date and Time of Production:

Example: (8008) 130113081520 - 13th January 2013 time 08.15.20

4 procedures
4. Procedures

I. Healthcare Primary Packaging (Optional )

The first level of packaging with bar code application will be implemented according to the developments in local and global market.

procedures
Procedures

II. Healthcare Secondary Packaging

a) Identify Healthcare Secondary Packaging by GTIN only (Mandatory)

Any of the following GS1 bar code symbologies (EAN-13, EAN-8, UPC-A, UPC-E) can be used, this is mandatory for Secondary items that are sold at Retail POS.

UPC-A

EAN-13

UPC-E

EAN-8

procedures1
Procedures
  • Healthcare Secondary Packaging

b) Using Additional Information with GTIN onHealthcare Secondary Packaging (Optional)

Any of the following GS1 bar code symbologies (GS1-128, GS1 DataMatrix, GS1 DataBar ) can be used

to encode the GTIN and the example additional data shown in bar code symbols at Secondary level

packaging:-

1) Unique Product identification code (GTIN-14 of secondary pack) using application identifier (01)

 2) Expiry Date in YYMMDD format using application identifier (17)

3) Batch/Lot Number using application identifier (10)

4) Serial No using application identifier (21)

5) Note that different combinations of the above can be used as needed.

Note:Each packaging level should have a different GTIN assigned per the GTIN Allocation Rules. For details refer to GS1 General Specification and the GS1 Healthcare GTIN Allocation Rules.

GS1 DataBar

GS1 DataMatrix

GS1-128

  • (17)010115(10) abc234

(01)0625123450011

(17)010115(10) abc2345

(01)06251234560011

procedures2
Procedures

II. Healthcare Secondary Packaging

  • GS1 DataMatrix (two dimensional) symbology is the preferred option.
  • GS1 DataMatrix symbology can encode product data in much smaller space than what is possible with one dimensional bar code symbology. This is an important consideration in healthcare sector due to very limited availability of printing space on product packaging, after complying with other statutory labeling & marking requirements.
  • JFDA mandates the implementation of Data Matrix in Jordan for all pharmaceutical products on Secondary Packaging in 2017.
procedures3
Procedures

III. Cases/Shipper (Optional )

a) Case / Shipper must be identified by GTIN, the following bar code Symbologies(GS1-128 or GS1 DataMatrix) with Application Identifier (01) should be used to encode a GTIN-13, GTIN-12, GTIN-8, GTIN-14.

Additional Information can be used as needed, such as:

 1) Serial No using application identifier (21)

2) Batch/Lot Number using application identifier (10)

3) Expiry Date in YYMMDD format using application identifier (17)

Example of GS1 bar code symbologies (GS1-128, GS1 DataMatrix)

GS1-128

GS1 DataMatrix

(01)06251234500024(21)ABC205001

procedures4
Procedures
  • b) If logistic unit:
  • 1- the requirements for the orderable trade item (homogeneous pack) as follows:- To generate the first barcode, GS1-128 and GS1 Data Matrix symbologies can be used with Product Identification (Unique GTIN-14 of Shipper pack) using application identifier (01)
  • - Other additional information can be used such as Serial Number, Batch Number, Expiry date.
  • - The second bar code: Serial Shipping Container Code(SSCC) must be used to identify
  • individual carton uniquely using application identifier (00) that requires GS1-128.

(Single Label for each shipper)

Note: Each packaging level should have a different GTIN assigned per the GTIN Allocation Rules. For details refer to GS1 General Specification and the GS1 Healthcare GTIN Allocation Rules.

procedures5
Procedures

2) The requirements for the logistics unit (heterogeneous pack):

If multiple items are packed in a shipper (heterogeneous pack), and / or the shipper level packaging is not an orderable unit, only second bar code should be present (i.e. SSCC ).

Human readable information on the label will be as per existing statutory labeling & marking requirements.

Schematic example of GS1-128 symbology for the logistics unit (heterogeneous pack) encoding above stated data at Case / Shipper is as below:

SSCC (Serial Shipping Container Code) to identify individual carton uniquely using application identifier (00)

5 general notes
5. General Notes
  • JFDA however reserves the right to modify the implementation of level of AIDC marking in future according to the market requirements.
  • Complete details on GS1 standards along with technical guidelines can be downloaded from (www.gs1jo.org.jo) or (www.gs1.org)
  • For any assistance, you can contact GS1 Jordan at 009626 562003 email – info@gs1jo.org.jo